Dosage and Administration :: VIVITROL Information

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Dosage and administration1

VIVITROL must not be administered intravenously
VIVITROL must be administered by a healthcare professional
As with any IM injection, VIVITROL should be administered with caution in patients with thrombocytopenia or any coagulation disorder
Administer once a month or every 4 weeks as a gluteal IM injection, alternating buttocks with each injection
If an individual misses a dose, instruct him/her to receive the next dose as soon as possible
Pretreatment with oral naltrexone is not required before using VIVITROL

More about VIVITROL administration1

The injection must be administered using the safety needle supplied and the carton components provided (see below).

VIVITROL® (naltrexone for extended-release injectable suspension) is supplied in single-use cartons. Each carton contains the items shown below.1

Carton contents

For more information about VIVITROL administration, please read the complete Prescribing Information including boxed warning for VIVITROL.

Frequently asked questions about VIVITROL preparation and administration

Can I prepare the suspension prior to my patient’s arrival?

No. You may remove the carton from the refrigerator prior to the patient's arrival, but once the diluent is added to the VIVITROL Microspheres, the dose should be mixed and the suspension administered immediately. It is very important to use proper aseptic technique when preparing the suspension. VIVITROL must be administered by a healthcare professional.

How much time do I have between preparing and administering the dose?

It is recommended that the suspension be administered immediately once the product has been suspended and transferred into the syringe. If a few minutes' delay occurs after suspension but before transfer into the syringe, the vial can be inverted a few times to resuspend and the contents then transferred into the syringe for immediate use.

Can I use needles or diluent other than those provided in the carton?

No. VIVITROL must be suspended only in the diluent supplied in the carton and must be administered with the needle supplied in the carton. All components (ie, the Microspheres, diluent, preparation needle, and an administration needle with safety device) are required for administration. A spare administration needle is provided in case of clogging. Do not substitute any other components for the components of the carton.

The suspension is milky white upon mixing with the diluent. Is this normal?

Yes. VIVITROL Microspheres will form a milky white suspension when mixed with the provided diluent.

What if a needle clog occurs during administration of the product?

If a clog occurs during administration, the needle should be withdrawn from the patient, capped with the attached safety device, and replaced with the spare administration needle provided. Gently push on the plunger until a bead of the suspension appears at the tip of the needle. The remainder of the suspension should then be administered into an adjacent site in the same gluteal region.

My patient missed an appointment. What do I do?

If a patient misses a dose, he/she should be instructed to receive the next dose as soon as possible. There are no data to specifically address the reinitiation of treatment in a patient who has previously discontinued treatment.

INDICATION1

VIVITROL® is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL.

Patients should not be actively drinking at the time of initial VIVITROL administration.

Treatment with VIVITROL should be part of a comprehensive management program that includes psychosocial support.

IMPORTANT SAFETY INFORMATION FOR VIVITROL1

VIVITROL is contraindicated in patients receiving opioid analgesics or with current physiologic opioid dependence, patients in acute opiate withdrawal, any individual who has failed the naloxone challenge test or has a positive urine screen for opioids, or in patients who have previously exhibited hypersensitivity to naltrexone PLG, carboxymethylcellulose or any other components of the diluent.

VIVITROL patients must be opioid free for a minimum of 7-10 days before treatment. Attempts to overcome opioid blockade due to VIVITROL may result in a fatal overdose. In prior opioid users, use of opioids after discontinuing VIVITROL may result in a fatal overdose because patients may be more sensitive to lower doses of opioids. Patients requiring reversal of the VIVITROL blockade for pain management should be monitored by appropriately trained personnel in a setting equipped for cardiopulmonary resuscitation.

Naltrexone has the capacity to cause hepatocellular injury when given in excessive doses

Naltrexone is contraindicated in acute hepatitis or liver failure, and its use in patients with active liver disease must be carefully considered in light of its hepatotoxic effects.

The margin of separation between the apparently safe dose of naltrexone and the dose causing hepatic injury appears to be only five-fold or less. VIVITROL does not appear to be a hepatotoxin at the recommended doses.

Patients should be warned of the risk of hepatic injury and advised to seek medical attention if they experience symptoms of acute hepatitis. Use of VIVITROL should be discontinued in the event of symptoms and/or signs of acute hepatitis.

VIVITROL is administered as a gluteal intramuscular injection. Inadvertent subcutaneous injection of VIVITROL may increase the likelihood of severe injection site reactions. VIVITROL must be injected using the customized needle provided in the carton. Because needle length may not be adequate due to body habitus, each patient should be assessed prior to each injection to assure that needle length is adequate for intramuscular administration. VIVITROL injection site reactions may be followed by pain, tenderness, induration, swelling, erythema, bruising or pruritus; however, in some cases injection site reactions may be very severe. Injection site reactions not improving may require prompt medical attention, including in some cases surgical intervention.

Consider the diagnosis of eosinophilic pneumonia if patients develop progressive dyspnea and hypoxemia. In an emergency situation in patients receiving VIVITROL, suggestions for pain management include regional analgesia or use of non-opioid analgesics. Alcohol dependent patients, including those taking VIVITROL, should be monitored for the development of depression or suicidal thoughts. Caution is recommended in administering VIVITROL to patients with moderate to severe renal impairment.

The most common adverse events associated with VIVITROL in clinical trials were nausea, vomiting, headache, dizziness, asthenic conditions and injection site reactions.

Please see VIVITROL Full Prescribing Information, including box warning by clicking on the link at the bottom of this page.